MYORX LOW DOSE PAIN RELIEVING - menthol cream 
PureTek Corporation

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient

Menthol  0.5%

Purpose

Topical Analgesic

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, sprains.

Warnings

For external use only.

Do not

  • apply on wounds or damaged skin
  • bandage tightly

When using this product

avoid contact with the eyes

Stop use and ask a doctor if

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days

Directions

Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.

Children under 2 years of age: consult a doctor.

Inactive ingredients

Aloe Barbadensis (Aloe Vera) Leaf Juice, Borago Officinalis Seed Oil, Capsaicin, Carbomer, Ceteareth-20, Cetearyl Alcohol, Cetyl Alcohol, Citric Acid, Eucalyptus Globulus Leaf Oil, Fructose, Menhaden Oil, Methyl Salicylate, Methylparaben, Phenoxyethanol, Propylene Glycol, Propylparaben, Purified Water, Squalane, Stearic Acid, Stearyl Alcohol, Tetrasodium EDTA, Tocopheryl Acetate (Vitamin E), Triethanolamine, Vitis Vinifera (Grape) Seed Oil.

Store at controlled room temperature 59°-86°F (15°-30°C).

Label

image of label

MYORX  LOW DOSE PAIN RELIEVING
menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59088-954
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 uL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BORAGE OIL (UNII: F8XAG1755S)  
CAPSAICIN (UNII: S07O44R1ZM)  
CARBOMER 934 (UNII: Z135WT9208)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
FRUCTOSE (UNII: 6YSS42VSEV)  
HYDROGENATED MENHADEN OIL (UNII: 736VD7888J)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PROPANEDIOL (UNII: 5965N8W85T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SQUALANE (UNII: GW89575KF9)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
EDETATE SODIUM (UNII: MP1J8420LU)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
TROLAMINE (UNII: 9O3K93S3TK)  
GRAPE SEED OIL (UNII: 930MLC8XGG)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59088-954-0559 mL in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/01/2011
Labeler - PureTek Corporation (785961046)
Establishment
NameAddressID/FEIBusiness Operations
PureTek Corporation785961046manufacture, label, pack, outsourcing human drug compounding, relabel, repack

Revised: 7/2011
Document Id: eb085e50-92cd-4c95-ac02-f4985d896af7
Set id: 1c8f98c8-f1bf-4489-bfd4-8ae3a35c2127
Version: 1
Effective Time: 20110701
 
PureTek Corporation